Systems and methods for tagging and tracking surgical devices and surgical accessories using radio frequency identification tags

ABSTRACT

Various systems and methods are provided for tagging and tracking surgical devices using radio frequency identification (RFID) tags. In general, the systems and methods allow for tracking surgical devices throughout distribution and sterilization thereof. In an exemplary embodiment, the system includes a tray configured to seat a plurality of surgical devices and having a parent RFID tag attached thereto that contains information and/or facilitates access to information about the tray and each of the surgical devices seated therein. Each of the surgical devices seated in the instrument tray can have attached thereto a child RFID tag containing information and/or facilitating access to information about the surgical device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/565,613 now U.S. Pat. No. 9,179,977 filed on Dec. 10, 2014 andentitled “Systems and Methods for Tagging and Tracking Surgical Devicesand Surgical Accessories Using Radio Frequency Identification Tags,”which is a continuation of U.S. application Ser. No. 13/668,645 now U.S.Pat. No. 8,937,544 filed on Nov. 5, 2012 and entitled “Systems andMethods for Tagging and Tracking Surgical Devices and SurgicalAccessories Using Radio Frequency Identification Tags,” each of which ishereby incorporated by reference in its entirety.

FIELD

The present disclosure relates generally to systems and methods fortagging and tracking surgical devices and surgical accessories usingradio frequency identification tags.

BACKGROUND

A traditional model for managing distribution of surgical devices andsurgical accessories includes several phases. These phases typicallyinclude inventory management, surgical preparation, and post-surgeryinventory management.

During the inventory management phase, a representative of a medicaldevice company orders various medical devices believed to be necessaryfor a particular surgery. The ordered medical devices are each labeledwith an identifier, such as a stock-keeping unit (SKU) number, a lotnumber, and/or a serial number. All of the ordered medical devices canbe packaged into a carrying tray, which can also be labeled with its ownidentifier, and shipped to the representative from the medical devicecompany or a distributor affiliated therewith. The identifiers of theordered medical devices and/or the carrying tray can be logged prior toshipment, thereby allowing the medical device company or the distributorto track which medical devices and/or carrying trays have been shipped.

During the surgical preparation phase, the representative can ensurethat all of the necessary devices are present in the tray. Theinstrument tray can be transferred to a hospital processing center,where the tray can be sterilized and prepared for surgery.

After the surgery, the representative identifies and manually documentsthe inventory that was consumed, including details of the surgery, e.g.,date, time, and a name of a surgeon who performed the surgery. Therepresentative obtains a purchase order from the hospital staff so thata seller, e.g., a surgical device company, can bill for the consumedinventory. The representative also ensures that consumed inventory isreplenished and that reusable medical devices are either returned to themedical device company or distributor or are prepared for subsequent useat the hospital.

There are a number of inefficiencies associated with existingdistribution management models. For example, the representative spends asignificant amount of time manually inspecting each surgical set andcompleting the accompanying paperwork. This time could be better spentsupporting more complex surgeries in which representative input iscrucial, or generating new business for the medical device company.Furthermore, there are significant costs associated with employing alarge staff of representatives. For another example, it takes asignificant amount of time to log ordered medical devices and carryingtrays prior to shipment and to log medical devices and carrying traysreturned after surgery. Precise tracking is necessary for, e.g.,inventory management and accurate billing, but the monetary and timecosts of conventional tracking methods are high.

In addition to being inefficient, conventional distribution managementsystems are subject to inaccuracy due to human error in manuallytracking and comparing identifiers. Each identifier has to beindividually checked, e.g., scanned with a bar code reader or manuallywritten down, etc. If any one identifier is accidentally missed orinaccurately recorded, inventory cannot be properly managed.Additionally, during shipment, identifiers can be damaged, such as withtorn packaging, which can render the identifiers useless.

Additionally, at least some conventional identifiers traditionallycannot undergo repeated sterilization because the intensity of thesterilization, e.g., extreme heat, damages the identifiers and/or causesthem to unattach, e.g., by unsticking, from packaging. This necessitatesreplacement of identifiers for medical devices and carrying trays andreturned to the medical device company or its distributor. Suchreplacement increases costs.

Accordingly, there remains a need for tagging and tracking surgicaldevices and surgical accessories.

SUMMARY

The present invention generally provides systems and methods for taggingand tracking surgical devices and surgical accessories using radiofrequency identification tags. In one aspect, a medical system isprovided that includes a surgical device carrying apparatus configuredto be transported between an inventory storage location at whichsurgical inventory is stored and a medical care facility at whichsurgical procedures are performed, a plurality of surgical devicesseated in the surgical device carrying apparatus and being configured tobe transported in the surgical device carrying apparatus between theinventory storage location and the medical care facility, a parent radiofrequency identification (RFID) tag attached to the surgical devicecarrying apparatus uniquely identifying the surgical device carryingapparatus and being configured to allow unique identification of each ofthe plurality of surgical devices seated in the surgical device carryingapparatus, and a plurality of child RFID tags. Each of the child RFIDtags uniquely identifies one of the plurality of surgical devices, eachof the child RFID tags is configured to be sterilized a plurality oftimes, and the parent RFID tag is configured to be sterilized aplurality of times.

The child RFID tags can be attached to the plurality of surgical devicesin a variety of ways. Each of the child RFID tags can be directlyattached to the one of the plurality of surgical devices that the childRFID tag uniquely identifies. Each of the child RFID tags can beremovably attached to the one of the plurality of surgical devices thatthe child RFID tag uniquely identifies.

The parent RFID tag can be attached to the surgical device carryingapparatus in a variety of ways. The parent RFID tag can be directlyattached to the surgical device carrying apparatus. The parent RFID tagcan be embedded within the surgical device carrying apparatus.

The medical system can include a plurality of lids. Each of theplurality of lids can be removably coupled to the surgical devicecarrying apparatus such that each of the plurality of lids can beremoved from the surgical device carrying apparatus independent of eachother. Each of the plurality of lids can be associated with one of theplurality of surgical devices and can be configured to prevent removalof the one of the plurality of surgical devices from the surgical devicecarrying apparatus until removed from the surgical device carryingapparatus. Each of the plurality of child RFID tags can be attached toone of the plurality of lids such that removing one of the plurality oflids from the surgical device carrying apparatus removes the child RFIDattached thereto from the surgical device carrying apparatus and allowsthe surgical device associated with the removed lid to be removed fromthe surgical device carrying apparatus.

The plurality of surgical devices can include at least one surgicalimplant configured to be implanted in a patient and/or at least onesurgical tool configured to be used in performing a surgical procedureon a patient. The at least one surgical implant can include a boneanchor having a recess formed therein the, and the child RFID tag forthe bone anchor can be attached to the bone anchor by being seated inthe recess.

In another aspect, a medical method is provided that includessterilizing a surgical device carrying apparatus seating a plurality ofsurgical devices, the surgical device carrying apparatus having a parentRFID tag attached thereto that uniquely identifies the surgical devicecarrying apparatus and that allows unique identification of each of theplurality of surgical devices, and each of plurality of surgical deviceshaving a child RFID tag attached thereto that uniquely identifies theone of the plurality of surgical devices to which the child RFID tag isattached. After the sterilizing, the surgical device carrying apparatuscan be received after a use of the surgical device carrying apparatus.After the receiving, the parent RFID tag and the child RFID tags of anyof the surgical devices remaining in the surgical device carryingapparatus can be scanned using an RFID tag reading device. The medicalmethod can also include determining if any one or more of the pluralityof surgical devices have been removed from the surgical device carryingapparatus based at least in part on the scanning of the parent RFID tagand the child RFID tags of any of the surgical devices remaining in thesurgical device carrying apparatus, and replacing in the surgical devicecarrying apparatus the determined one or more of the plurality ofsurgical devices with one or more replacement surgical devices. Each ofthe one or more replacement surgical devices can have a child RFID tagattached thereto that uniquely identifies the one of the replacementsurgical devices to which the child RFID tag is attached. After thedetermining and the replacing, the surgical device carrying apparatuscan be resterilized with the surgical carrying apparatus having theparent RFID tag attached thereto, having the non-removed plurality ofsurgical devices seated therein with their associated child RFID tagsattached thereto, and having the one or more replacement surgicaldevices seated therein with their associated child RFID tags attachedthereto. The sterilizing, receiving, scanning, determining, replacing,and resterilizing can be repeated a plurality of additional times. Theuse of the surgical device carrying apparatus can include at least oneof a transport of the surgical device carrying apparatus from a firstgeographic location to a second geographic location that is differentfrom the first geographic location, and presence of the surgical devicecarrying apparatus in a setting of a surgical procedure during which oneor more of the plurality of surgical devices is configured to be used.

In another embodiment, a medical method is provided that includesscanning a parent RFID tag attached to a surgical device carryingapparatus seating a plurality of surgical devices, the parent RFID taguniquely identifying the surgical device carrying apparatus and allowingunique identification of each of the plurality of surgical devicesseated in the surgical device carrying apparatus. A plurality of childRFID tags can be scanned, each of the child RFID tags uniquelyidentifying one of the plurality of surgical devices. After scanning theparent RFID tag and the plurality of child RFID tags, the surgicaldevice carrying apparatus can be sterilized, the surgical devicecarrying apparatus having the parent RFID tag attached thereto andhaving the plurality of surgical devices seated therein with the childRFID tags attached thereto. After sterilizing the surgical devicecarrying apparatus, the parent RFID tag attached to the surgical devicecarrying apparatus can be rescanned. The method can also includedetermining, based at least in part on the rescanning of the parent RFIDtag, which of the plurality of surgical devices remain seated in thesurgical device carrying apparatus. The scanning, sterilizing,rescanning, and determining can be repeated a plurality of additionaltimes.

After determining which of the plurality of surgical devices remainseated in the surgical device carrying apparatus, the surgical devicecarrying apparatus can be restocked to replace any of the plurality ofsurgical devices not remaining seated in the surgical device carryingapparatus. Each of the restocked surgical devices can have attachedthereto a child RFID tag uniquely identifying the restocked surgicaldevice to which the child RFID is attached. The method can also includecausing the parent RFID tag to allow unique identification of each ofthe one or more restocked surgical devices. The surgical device carryingapparatus can be resterilized, the surgical device carrying apparatushaving the parent RFID tag attached thereto, having the remainingplurality of surgical devices seated therein with the child RFID tagsattached thereto, and having the restocked surgical devices seatedtherein with the child RFID tags attached thereto. After resterilizing,the parent RFID tag attached to the surgical device carrying apparatuscan be rescanned. The method can further include determining, based atleast in part on the rescanning of the parent RFID tag, which of theremaining plurality of surgical devices and the restocked surgicaldevices remain seated in the surgical device carrying apparatus.

After scanning the parent RFID tag and the plurality of child RFID tags,the surgical device carrying apparatus having the plurality of surgicaldevices seated therein can be transported from a first location to asecond location. The surgical device carrying apparatus having theparent RFID tag attached thereto and having the plurality of surgicaldevices seated therein with the child RFID tags attached thereto can besterilized at the second location. The surgical device carryingapparatus and each of the plurality of surgical devices remaining in thesurgical device carrying apparatus can be transported from the secondlocation to the first location. The parent RFID tag attached to thesurgical device carrying apparatus and each of the child RFID tagsremaining in the surgical device carrying apparatus can be rescanned atthe second location. The scanning, sterilizing, rescanning, anddetermining can be repeated a plurality of additional times. Thesurgical device carrying apparatus can be transported from the firstlocation after each of the repeated scannings.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a top view of one embodiment of an implant tray having aplurality of spinal anchors seated therein, each of the spinal anchorshaving an RFID tag assembly attached thereto;

FIG. 2 is a top view of the implant tray of FIG. 1 without the spinalanchors seated therein;

FIG. 3A is a side view of a spinal anchor assembly that includes thespinal anchor of FIG. 1;

FIG. 3B is a perspective view of a set screw of the spinal anchorassembly of FIG. 3A;

FIG. 3C is a side view of the set screw of FIG. 3B;

FIG. 4 is a side view of one of the child RFID tag assemblies of FIG. 1;

FIG. 5 is a top view of the child RFID tag assembly of FIG. 4;

FIG. 6 is a side view of the spinal anchor of FIG. 3A attached to thechild RFID tag assembly of FIG. 4;

FIG. 7 is a side view of another embodiment of an implant tray having aplurality of spinal anchors seated therein, each of the spinal anchorshaving an RFID tag assembly attached thereto;

FIG. 8 is a side, partially transparent view of the implant tray of FIG.7;

FIG. 9 is a top view of an embodiment of an implant tray having aplurality of cervical screws seated therein underneath a plurality oflids;

FIG. 10 is a top view of the implant tray of FIG. 9 with one of the lidsremoved;

FIG. 11 is a side view of the implant tray of FIG. 9;

FIG. 12 is a top view of an embodiment of an implant tray having aplurality of set screws seated therein underneath a plurality of lids;

FIG. 13 is a top view of the implant tray of FIG. 12 with one of thelids removed;

FIG. 14 is a side view of the implant tray of FIG. 12,

FIG. 15 is a perspective view of an embodiment of an instrument trayconfigured to seat a plurality of surgical devices, the instrument trayhaving a parent RFID tag attached thereto;

FIG. 16 is a side view of an embodiment of a surgical instrument havinga child RFID tag attached thereto; and

FIG. 17 is a flowchart showing one embodiment of a process of surgicaldevice distribution.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment can be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

Various systems and methods are disclosed for tagging and trackingsurgical devices and surgical accessories using radio frequencyidentification (RFID) tags. In general, the systems and methods allowfor tracking surgical devices and surgical accessories, collectivelyreferred to herein as “surgical devices,” throughout distribution andsterilization thereof. In an exemplary embodiment, the system includes asurgical device carrying apparatus, also referred to herein as aninstrument tray, an implant tray, and a tray, configured to seat aplurality of surgical devices, which can be same or different from oneanother. A parent RFID tag containing information and/or facilitatingaccess to information about the tray and each of all the surgicaldevices stored in the tray can be attached to the tray. In addition,each of the surgical devices seated in the tray can have attachedthereto a child RFID tag containing information and/or facilitatingaccess to information about the surgical device to which the child RFIDtag is attached. RFID tags can be quickly scanned, such as manually, orautomatically, e.g., using an external reading device mounted to an trayconveyer belt, thus increasing the efficiency of surgical devicedistribution. Identifying trays and surgical devices using RFID tags canallow surgical devices missing from the tray to be identified at anytime by comparing information gathered as a result of a scan of theparent RFID tag attached to the tray to information gathered as a resultof a scan of all the child RFID tags attached to surgical devices seatedwithin the tray, if any. Comparison of the parent RFID tag's associatedinformation about the surgical devices with the child RFID tags'associated information about their respective surgical devices can bemanual, but in an exemplary embodiment the comparison can be automated,which can further enhance the efficiency of the comparison. In anexemplary embodiment, the parent RFID tag and the child RFID tags can beconfigured to be sterilized multiple times while maintaining theirfunctionality, thereby allowing the tray to be repeatedly used to carrysurgical devices between geographic locations and/or allowing unusedsurgical devices to remain in the tray through multiple shipping cycles,thus saving time and labor. The parent RFID tag and the child RFID tagscan be configured to be reprogrammed any number of times to identifydifferent surgical devices through multiple distribution cycles. Thus,the parent RFID tag can remain permanently attached to the tray asdifferent surgical devices are seated within the tray, and/or the childRFID tags can be reused to identify different surgical devices. Theparent RFID tag can be directly attached to the tray, e.g. embeddedtherein, thus helping to prevent accidental detachment of the parentRFID tag from the tray. The child RFID tags can be attached to theirrespective surgical devices using one or more features of the surgicaldevices themselves, such as recesses or threads formed on the surgicaldevices, which can allow the child RFID tags to be attached to surgicaldevices without using packaging wrapped around or otherwise adhered tothe surgical devices, thus saving money and physical resources.

FIG. 1 illustrates one exemplary embodiment of an implant tray 100configured to seat a plurality of surgical devices therein. The surgicaldevices seated in the implant tray 100 in FIG. 1 include a plurality ofbone anchors, e.g., spinal anchors, obscured in FIG. 1 but shown inFIGS. 3 and 6. However, as discussed further below, the implant tray100, as well as other embodiments of trays discussed herein, can beconfigured to seat any kind of surgical device, or any combination ofsame and/or different surgical devices.

The implant tray 100, shown in FIG. 2 without any surgical devicesseated therein, can have a variety of sizes, shapes, and configurations.It will be appreciated by a person skilled in the art that the implanttray 100 shown in FIGS. 1 and 2 is an illustrative, non-limiting exampleof an implant tray that can be used to seat surgical devices and have aparent RFID tag attached thereto. Other trays illustrated herein aresimilarly non-limiting examples. Trays which are configured to retainspecific surgical devices and/or accessories are typically customdesigned by a manufacturer of the devices and/or accessories.

The tray 100 can have a top panel 102 with a plurality of recesses 104formed therein. Each of the recesses 104 can be configured to seat asurgical device such that the tray 100 can seat a plurality of surgicaldevices. The recesses 104 can have a variety of sizes, shapes, andconfigurations, but can generally be configured to securely, safely seata surgical device therein. In the illustrated embodiment, each of therecesses 104 is configured to seat one spinal anchor, but each of therecesses 104 can be configured to seat any number of surgical devicesand other types of surgical devices, the same or different from anyother recesses 104 in the tray 100. Each of the recesses 104 can includea top recess 104 a and a bottom recess 104 b. The top and bottomrecesses 104 a, 104 b can each have a size, e.g., a diameter, a depth,etc., corresponding to a portion of the surgical device to be seatedtherein and can be arranged in the tray 100 in any way. As shown in theillustrated embodiment, the recesses 104 can be arranged in a pluralityof parallel, linear rows a, b, c, d, e, f and a plurality of parallel,linear columns 1, 2, 3, 4, 5. As will be appreciated by a person skilledin the art, the recesses 104 can be configured to receive surgicaldevices therein in any orientation.

The tray 100 can be labeled with one or more items of information 105 intext and/or graphical format, such as names of surgical devices to beseated therein, to help facilitate use of the tray 100 and/or to helpallow for manual inspection of the information 105. The tray 100 can beconstructed of any one or more materials, as will be appreciated by aperson skilled in the art, such as material(s) that are configured toundergo sterilization and to support a weight of surgical devices seatedtherein.

The tray 100 can have a parent RFID tag 107 attached thereto, which canfacilitate identification of the tray 100 and any surgical devicesseated therein, as mentioned above. The parent RFID tag 107 can beattached to the tray 100 in a variety of ways, as will be appreciated bya person skilled in the art. In an exemplary embodiment, the parent RFIDtag 107 can be embedded within the tray 100, which can help preventdamage to the parent RFID tag 107 during transport and duringunloading/reloading of the tray 100, and/or can facilitate repeatedshipments of the tray 100 between different geographic locations. Theparent RFID tag 107 can be embedded within the tray 100 in a variety ofways, such as by being embedded therein during manufacture of the tray100. As in the illustrated embodiment, the tray 100 can include a cavity106 formed therein that can be configured to seat the parent RFID tag107 therein so as to embed the parent RFID tag 107 in the tray 100. Thecavity 106 can be formed in the tray 100 in any manner and in anylocation of the tray 100. The parent RFID tag 107 can optionally besecured in the cavity 106 using an adhesive. The tray 100 can include a“door” or lid (not shown) configured to be selectively opened and closedto allow for selective access to the cavity 106, thus reducing chancesof accidental displacement of the parent RFID tag 107 duringtransportation of the tray 100 and/or allowing for intentional removalof the parent RFID tag 107 from the cavity 106, such as for use of theparent RFID tag 107 with another tray or to replace the parent RFID tag107 with a newer generation RFID tag. The “door” or lid can thereforeallow for removal and replacement of the parent RFID tag 107 containedwithin the cavity 106. The parent RFID tag 107 can be permanentlyattached to the tray 100 in a number of other ways, such as by beingaffixed to an exterior surface thereof with an adhesive.

The parent RFID tag 107 can be attached to the tray 100 in a way thatallows the tray 100 to be transported between geographical locations,e.g., between a medical device warehouse and a hospital, without theparent RFID tag 107 being exposed on an exterior surface of the tray100, and/or without the parent RFID tag 107 being visible to the nakedeye, which can help protect the parent RFID tag 107. “Hiding” the parentRFID tag 107 can help prevent damage to the parent RFID tag 107 duringtransport and during unloading/reloading of the tray 100, and canfacilitate repeated shipments of the tray 100 between differentgeographic locations.

The parent RFID tag 107 can be any of various types of RFID tags. In anexemplary embodiment, the parent RFID tag 107 can be configured toundergo multiple sterilizations without losing data stored thereon andwhile otherwise maintaining its functionality. The parent RFID tag 107can thus be repeatedly used with same tray 100 through numerousdistribution cycles, thereby saving labor and resources. Non-limitingexamples of an RFID tag that can be sterilized multiple times are theSentry AST™ Autoclave tag available from Vizinex RFID of Quakertown, Pa.and the TegoChip™ available from Tego, Inc. of Waltham, Mass.Non-limiting examples of an RFID tag that can be attached to or embeddedin a surgical device are the XS Series of RFID Tags (Dot XS and Dash XS)available from Xerafy of Hong Kong, which are manufactured using aceramic material and can be attached to or embedded in individualmedical devices and/or surgical device carrying apparatuses.

The parent RFID tag 107 can be configured to store information, as willbe appreciated by a person skilled in the art. The information canuniquely identify the tray 100, e.g., by identification number,alphanumeric code, etc., and can allow unique identification of eachsurgical device seated in the tray 100. The parent RFID tag 107 canadditionally or alternatively be configured to store information relatedto the use of the tray 100 and/or any surgical devices seated therein,such as how many times the tray 100 has been sterilized or transportedbetween various geographic locations. The parent RFID tag 107 can bereprogrammable to allow for, e.g., updates to a status of the tray 100,changes in the surgical devices seated in the tray 100, etc., such as inbetween surgical procedures.

In one embodiment, the parent RFID tag 107 can be configured to allowunique identification of each surgical device by storing a “master” listof surgical device and/or child RFID tag identification numbers,alphanumeric codes, etc. In other words, the RFID tag 107 can beconfigured to store information uniquely identifying each of thesurgical device(s) seated in the tray 100 to which the parent RFID tag107 is attached. The parent RFID tag 107 locally storing informationregarding the surgical device(s) seated in the tray 100 associated withthe tag 107 can reduce an amount of equipment needed to identify traysand various devices seated therein, which can help reduce cost.Alternatively or additionally, the parent RFID tag 107 can be configuredto allow unique identification of each surgical device by theinformation uniquely identifying the tray 100 allowing access toexternally stored information regarding the surgical device(s). In otherwords, the RFID tag 107 can be configured to store information thatallows unique identification of surgical device(s) without storing,e.g., in the RFID tag's memory,″ information uniquely identifying eachof the surgical device(s), e.g., without storing surgical device and/orchild RFID tag identification numbers, alphanumeric codes, etc. Fornon-limiting example, the information uniquely identifying the tray 107,e.g., an identification number, alphanumeric code, etc., can be lookedup in an externally stored database including data regarding a pluralityof trays and surgical device(s) seated in each one of the trays. Thesurgical device(s) associated with the tray 107 can therefore beuniquely identified. As will be appreciated by a person skilled in theart, the externally stored database external to the tray 100 can belocated in any one or more storage mechanisms, such as in a desktopcomputer's memory, a standalone external hard drive, a server's memory,a laptop computer's memory, etc. For another non-limiting example, theinformation stored in the parent RFID tag 107 can include a direct linkto the tray's information stored in the externally stored database.Using a database to store information instead of locally storinginformation on the parent RFID tag 107 can help reduce a size of theparent RFID tag 107 since the parent RFID tag 107 can have a relativelysmall memory, which can help make the parent RFID tag 107 easier toattach to the tray 100 and/or help reduce monetary cost of the parentRFID tag 107. Locally storing information in the parent RFID tag 107 andusing a database to store the information can provide redundancy, whichcan help protect against data loss.

As mentioned above, although the tray 100 can be configured to seat anynumber and any combination of different types of surgical devices, thetray 100 in the illustrated embodiment is configured to seat a pluralityof the spinal anchors. FIG. 3A illustrates an exemplary embodiment of aspinal anchor that can be seated in the tray 100 and that can beconfigured to have a child RFID tag 132 (see FIG. 6) attached thereto.The spinal anchor can include a head 122 and a shank 124 extendingdistally from the head 122. The spinal anchor can be part of a spinalanchor assembly 120 that also includes a set screw 128 configured to beat least partially seated in the head 122. FIGS. 3B and 3C alsoillustrate the set screw 128. The head 122 can have a recess 130 formedtherein that can be configured to seat a spinal fixation element, e.g.,a spinal rod 131. The head 122 can be integral with the shank 124, orthe head 122 can be a separate, discrete member configured to seat aproximal end of the shank 124 therein, e.g., as with a polyaxial screw.The shank 124 can have one or more bone-engaging features formedthereon, e.g., a thread 126, configured to secure the shank 124, andhence the spinal anchor assembly 120, to bone. The set screw 128 canhave a thread 129 formed thereon configured to threadably engage acorresponding thread (obscured in FIG. 3A) formed on a surface of therecess 130, such that the set screw 128 can be seated at least partiallywithin the head 122. The set screw 128 can thus be configured to securethe spinal rod 131 within the recess 130. It will be appreciated by aperson skilled in the art that the spinal anchor assembly 120 is anillustrative, non-limiting example of a spinal anchor assembly and ofthe various types of surgical devices that can be seated in a tray andcan have a child RFID tag attached thereto.

The child RFID tag 132 can be attached to the spinal anchor seated inthe tray 100 in a variety of ways. The child RFID tag 132 can beremovably attached to the spinal anchor, which can facilitateidentification of the spinal anchor, as mentioned above, while allowingfor removal of the child RFID tag 132 from the spinal anchor beforeimplantation of the spinal anchor in the body. The removed child RFIDtag 132 can then be disposed of or can be retained for use with anothersurgical device. Similarly, the set screw 128 can have a child RFID tagattached thereto, e.g., as discussed below with reference to FIGS.12-14. In another embodiment, a child RFID tag can be permanently (e.g.,non-removably) attached to a surgical device configured to be seated ina tray. In an exemplary embodiment, a child RFID tag can be removablyattached to an implantable surgical device, e.g., the spinal anchorassembly 120, a spinal plate, a bone anchor (e.g., a suture anchor, aspinal anchor, etc.), a surgical staple, a surgical clip, a screw, etc.,thereby allowing the child RFID tag to be removed from the implant suchthat the child RFID tag is not implanted within a patient. Removal ofthe child RFID tag from the surgical device can indicate that thesurgical device was used, thereby allowing a charge for the surgicaldevice to be assessed and billed, e.g., by a medical device company.Conversely, a child RFID tag not being removed from the surgical devicecan indicate the reverse, that the surgical device was not used suchthat a customer should not be billed for the surgical device. Similarly,in an exemplary embodiment, a child RFID tag can be permanently attachedto a non-implantable surgical device, e.g., a surgical stapler, aretractor, a scalpel, scissors, a trocar, etc., which can allow thechild RFID tag to uniquely identify the non-implantable surgical devicesthrough multiple shipping cycles and/or through the device's use inmultiple surgical procedures. A child RFID tag can, however, beremovably attached to a non-implantable surgical device, which canfacilitate billing for used surgical devices, as discussed above.

As shown in FIG. 4, the child RFID tag 132 can be attached to a thumbgrip 108 as part of a child RFID tag assembly 133 that can assist inattaching and removing the child RFID tag 132 to and from the spinalanchor. The child RFID tag assembly 133 in the illustrated embodiment isconfigured to threadably mate with the spinal anchor, as discussedfurther below, but child RFID tag assemblies can have a variety ofconfigurations configured to removably mate with different surgicaldevices. For non-limiting example, a child RFID tag assembly configuredto removably attach to a bone plate, e.g., a spinal plate, can include alocking ring having a child RFID tag attached thereto, e.g., embeddedtherein. The locking ring can be configured to be snapped open andclosed, similar to a bracelet or a binder ring, such that the lockingring can be selectively inserted through and removed from a boreextending through the bone plate.

Referring again to the embodiment of FIG. 4, the thumb grip 108 caninclude an annular disc 110 having a top face 112 and a protrusion 114extending proximally therefrom and having a top face 116, although thethumb grip 108 can be configured in a variety of other ways. Generally,the child RFID tag assembly 133 can be configured to facilitate easyhand gripping thereof. The thumb grip 108 can have a distal portion 136including a thread 136 t formed thereon. The thread 136 t can beconfigured to threadably mate with the thread formed on the surface ofthe recess 130 of the spinal anchor's head 122, thereby allowing thechild RFID tag assembly 133 to be removably attached to the spinalanchor. The thread 136 t can extend along any amount of the distalportion 136, including around an entirety of the distal portion 136 andalong an entire longitudinal length of the distal portion 136, but in anexemplary embodiment, the thread 136 t can extend around a minimalamount of the distal portion 136, e.g., extending down less than halfthe longitudinal length of the distal portion 136 and extending aroundmore than one full circumference but less than two full circumferencesaround the distal portion 136, as shown in FIGS. 4 and 6. Having aminimal amount of threading can facilitate easy insertion and removal ofthe child RFID tag assembly 133 from the head 122 prior to use, e.g., ina hospital operating room, while still securely holding the child RFIDtag assembly 133 thereto so as to help prevent accidental unthreadingduring shipment between different geographic locations. In an exemplaryembodiment, the child RFID tag 132 can be attached to the distal portion136 of the thumb grip 108 using a rod 138 extending distally from thedistal portion 136 and passing through a bore 135 formed in a casing 134encasing the child RFID tag 132. The casing 134 can have a size and ashape configured to be seated in the recess 130 formed in the head 122,as shown in FIG. 6. A knob 140 at a distal end of the rod 138 can have adiameter that is larger than a diameter of the bore 135 in the casing134 so as to secure the casing 134, and hence the child RFID tag 132,between the knob 140 and the distal portion 136. The rod 138 can bemovably coupled to the casing 134 such that rotation of the thumb grip108, including the distal portion 136, as shown in FIG. 5, can rotatethe rod 138 relative to the casing 134, and hence the child RFID tag132, e.g., does not cause rotation of the casing 134 and the child RFIDtag 132. The thumb grip 108 can thus assist a user in attaching andremoving the child RFID tag assembly 133 from the head 122 of the spinalanchor without affecting corresponding rotation of the casing 134, thechild RFID tag 132, or the spinal anchor.

The child RFID tag assembly 133 can include identification information117 thereon that identifies the spinal anchor attached thereto, as shownin FIG. 5. In the illustrated embodiment, the top faces 112, 116 of thethumb grip 108 are labeled with the information 117, but the information117 can be located in any one or more places on the child RFID tagassembly 133. The information 117 can include any number of identifyingcharacteristics, including, by way of non-limiting example, informationrelated to surgical device size, e.g., diameter, length, etc., andinformation related to part and lot numbers. As shown in FIG. 1, theinformation 117 can be visible when the spinal anchor having the childRFID tag assembly 133 attached thereto is seated in the tray 100, whichcan allow for manual inspection of the information 117.

In another embodiment (not shown), the child RFID tag 132 can be securedto the spinal anchor by placing the casing 134, including the child RFIDtag 132, within the recess 130 of the spinal anchor's head 122 andscrewing the set screw 128 into the head 122 above the casing 134 andthe child RFID tag 132, without the assistance of the child RFIDassembly 133, e.g., without the thumb grip 108 (including the distalportion 136) and the rod 138. The set screw 128 can therefore hold thecasing 134 within the recess 130 by exerting a distal force thereon.Because the set screw 128 will typically have to be removed beforeimplantation of the spinal anchor assembly 120 within a patient, inparticular to open up the recess 130 such that it can accommodate thespinal rod 131, removing the set screw 128 will necessarily involve theremoval of the child RFID tag 132, thus minimizing the risk ofaccidentally implanting the child RFID tag 132 within a patient.

In yet another embodiment (not shown), the thumb grip 108 can beconfigured to have the child RFID tag 132 attached thereto instead ofhaving the child RFID tag 132 within the casing 134. The child RFID tagassembly in this embodiment would thus not need to include the casing134 or the rod 138, which can simplify and/or lower cost ofmanufacturing.

The spinal anchor, the child RFID tag assembly 133, and/or the tray 100can be labeled with a reminder (not shown) to remove the child RFID tag132 or the child RFID tag assembly 133, in particular when the childRFID tag 132 is not readily visible to the naked eye, e.g., the childRFID tag 132 is seated within the spinal anchor underneath a componentthat would not otherwise need to be removed before implantation of thespinal anchor.

Modifications on any surgical device can similarly be configured toaccommodate the child RFID tag 132, e.g., a recess formed on an exteriorsurface of the surgical device or a closed cavity having a “door” or lidconfigured to be selectively opened and closed, thus reducing thechances of accidental displacement during transportation but allowingfor intentional removal, e.g. before implantation in the case ofsurgical implants. For surgical devices, the child RFID tag 132 can becompletely embedded or enclosed in a closed cavity in any part of thesurgical device, such that it is not easily removed or is not able to beremoved at all. As with the parent RFID tag 107, this can help toprevent damage to the child RFID tag 132 during transport andunloading/reloading of the tray 100, and can facilitate repeatedshipments of the surgical device between different geographic locations.

Like the parent RFID tag 107 discussed above, the child RFID tag 132 canbe any type of RFID tag and, in an exemplary embodiment, can beconfigured to undergo multiple sterilizations. Each child RFID tag 132can be the same as or different from other child RFID tags 132 attachedto surgical devices seated within the tray 100. The child RFID tag 132can thus be configured to store information similar to that discussedabove regarding the parent RFID tag 107. By way of non-limiting example,the information can include information uniquely identifying thesurgical device to which the child RFID tag 132 is attached andinformation relating to a location of the surgical device to which thechild RFID tag 132 is attached in the tray 100, e.g., the child RFID tag132 attached to the spinal anchor in row a, column 1 (see FIG. 1)indicates that the spinal anchor is seated in a position a1 of the tray100. For surgical devices that can be reused, a child RFID tag can storeuse information relating to its associated surgical device, such as howmany times the surgical device has been used in surgery or transportedbetween different geographic locations, which can help trigger anynecessary maintenance of the device and/or otherwise indicate if thedevice should be temporarily or permanently pulled out of service.

Below are discussions of various other embodiments of trays, eachconfigured to seat a plurality of surgical devices. The variousembodiments discussed below can generally be configured and usedsimilarly to the tray 100 of FIGS. 1 and 2. Additionally, like-namedelements and like-illustrated elements of trays and surgical devicesdiscussed herein can be configured and used similar to one another.

FIGS. 7 and 8 illustrate another embodiment of an implant tray 200configured to seat a plurality of surgical devices therein. The tray 200can include a suspended shelf 250 configured to seat a plurality ofsurgical devices therein. The tray 200 can include a lid 246 at aproximal end thereof, which can help reduce a likelihood of damage,loss, and/or contamination of surgical devices seated in the tray 200.To assist a user in attaching/removing or opening/closing of the lid246, a grip or handle (not shown) can be formed on the lid 246. Thesuspended shelf 250 can have a plurality of recesses 204 formed therein,each of which can be configured to seat at least a portion of a surgicaldevice, such that part of the surgical device can extend proximally,e.g., toward the lid 246, and/or distally from the shelf 250. Therecesses 204 can be arranged in a single row longitudinally aligned withone another on the shelf 250, as shown, but the recesses 204 can bearranged in any other way, e.g., in any pattern, in multiple rows, etc.The shelf 250 can be suspended above a bottom panel 242 of the tray 200,such as by attachment to side panels 244 a, 244 b extending between thelid 246 and the bottom panel 242, and at a height that allows forsurgical devices to be completely contained within the tray 200 betweenthe lid 246 and the bottom panel 242. It will be appreciated by a personskilled in the art that the shelf 250 can be removably attached to theside panels 244 a, 244 b and/or can be adjusted to different heights toaccommodate different types and/or sizes of surgical devices. The shelf250 can be integral to the side panels 244 a, 244 b or can be movable,e.g., slideable along a slot (not shown) extending in a longitudinaldirection along the side panels 244 a, 244 b. The tray 200 can have twoadditional side panels (not shown) to form a closed container, which canhelp protect surgical devices seated in the tray 200. The tray 200 canbe labeled with information 205 in text and/or graphical format, similarto the information 105 discussed above with respect to the tray 100.

A parent RFID tag 207 can be attached to the tray 200 in any way,similar to that discussed above regarding the parent RFID tag 107 ofFIGS. 1 and 2. In the illustrated embodiment, as shown in FIG. 7, theparent RFID tag 207 is embedded within the shelf 250 in a closed cavity206 formed therein.

Although the tray 200 can be configured to seat any combination of thesame or different types of surgical devices, the tray 200 in theillustrated embodiment is configured to seat a plurality of spinalanchors 220, each of which can be attached to a child RFID tag assembly233, similar to the spinal anchor and the child RFID tag assembly 133 ofFIG. 1 discussed above. As shown in FIG. 8, the shelf 250 can beconfigured to seat one of the spinal anchors 220 and its attached childRFID tag assembly 233 in each of the recesses 204, such that each of thespinal anchors 220 is seated fully within the tray 200, along with theirassociated child RFID tag assemblies 233. The tray 200 in theillustrated embodiment is configured as a kit including a plurality ofthe spinal anchors 220, each having a different shank length tofacilitate selection of an appropriately sized spinal anchor 220 for aspecific patient having a spinal procedure performed thereon. The tray100 of FIG. 1 is similarly configured as a kit including a plurality ofdifferently sized spinal anchors, e.g., each of the columns 1, 2, 3, 4,5 including spinal anchors having a same shank length.

As shown, the lid 246 can be configured to slidably move in notches 248a, 248 b formed in the side panels 244 a, 244 b along a planesubstantially parallel to the bottom panel 242, thus allowing forselective access to the surgical anchors 220. It will be appreciated bya person skilled in the art that the lid 246 can be removably attachedto the side panels 244 a, 244 b in any way, e.g., by protrusions (notshown) on the side panels 244 a, 244 b that slidably fit into notches(not shown) on the lid 246, by a snap-fit mechanism that allows a userto attach and remove the lid 246 by vertical movement, etc. In anotherembodiment, the lid 246 can be permanently attached to the side panels244 a, 244 b and can be configured to open and close, e.g., with a hinge(not shown) or a sliding mechanism (not shown) having a lock configuredto prevent the lid 246 from sliding out of the notches 248 a, 248 bentirely.

FIGS. 9-11 illustrate yet another embodiment of an implant tray 300configured to seat a plurality of surgical devices therein. The tray 300can have a plurality of removable lids 346 attached thereto. Each of theremovable lids 346 can be configured to cover one of a plurality ofrecesses 304 formed in the tray 300 and can have a child RFID tag 332attached thereto. As shown in FIG. 10, removing any one of the lids 346(a left-most lid 346 is shown removed in FIG. 10) can allow a user todiscard the child RFID tag 332 attached thereto and allow the user toaccess a surgical device seated within the newly exposed recess 304. Thetray 300 can thus be particularly useful for seating and transportingsurgical devices to which attachment of the child RFID tag 332 directlythereto, as in the embodiments illustrated in FIGS. 1-8, could bedifficult, such as with extremely small and/or extremely delicatesurgical devices. The recesses 304 can have any shape, such as arectangular box shape, as in the illustrated embodiment, which can allowthe tray 300 to accommodate a variety of surgical devices, including, byway of non-limiting example, surgical devices of a variety of shapes andsizes. Any one or more of the recesses 304 can optionally have asecuring feature (not shown), such as adjustable fasteners or a lightadhesive, configured to removably secure a surgical device in placewithin the recess 304 whether or not the lid 346 is open/on orclosed/off, which can help prevent jostling and accordant damage of thesurgical device prior to surgical use. The recesses 304 can be arrangedin a single, longitudinally-aligned row along a top panel of the tray300 as shown, but can be arranged in any pattern and/or in multiplerows. Similar to that discussed above, the tray 300 can be labeled withinformation 305 and can have a parent RFID tag 307 attached thereto,e.g., in an enclosed cavity 306 as shown.

The lids 346 can have a variety of sizes, shapes, and configurations.The lids 346 can each include a top face 352 disposed on a top panel 302of the tray 300 and a side face 354 disposed on a side panel 303 of thetray 300, although the lids 346 can have any number of faces formed onany panels of the tray 300. Each of the lids 346 can be configured to beremoved independently of the other lids 346, such as by a sliding motionparallel to the top face 352 and toward the side face 354 of the lid346, although the lids 346 can be attached to the tray 300 by anycoupling mechanism that allows for removal of its associated lid 346,e.g., by corresponding engagement features on the lid 346 and the tray300. In an exemplary embodiment, the lids 346 can be configured to beentirely removed from the tray 300, which can allow the lids 346 to bedisposed of after removal from the tray 300, thereby indicating that thesurgical device exposed by the removal of the lid 346 was used in asurgical procedure and/or should be charged for as being used in asurgical procedure. The lids 346 can be configured to benon-reattachable to the tray 300 once removed therefrom, which can helpfacilitate billing by allowing for all removed lids 346 to indicate abilling charge. As discussed further below, the lid 346 can have a childRFID tag 332 attached thereto, which can be disposed of along with theremoved lid 346. A thumb grab 356 can be formed on the top face 302 ofthe lid 346, which can help to provide frictional force to assist a userin slidably removing the lid 346. The thumb grab 356 can be located onany portion of the lid 346 and can take any form. In the illustratedembodiment, the thumb grab 356 includes a circular plate having atextured grip surface 358 formed on at least a portion thereof.

The child RFID tag 332 can be attached to any portion of the lid 346 inany number of ways, such as by being attached to an exterior surface ofthe lid 346, being seated in a recess (not shown) formed on the lid 346,or being embedded or encapsulated in a closed cavity 335 formed in thelid 346. The child RFID tag 332 can contain information that canuniquely identify the surgical device seated within the recess 304 thatis covered by the lid 346 to which the child RFID tag 332 is attached.To help ensure that the lid 346 and the attached child RFID tag 332 arediscarded upon removal of the surgical device seated within the recess304 beneath the lid 346 and to assist with accounting of surgicaldevices removed from the tray 300, the tray 300 can be labeled with aninstruction 347 to discard the lid 346 upon removal thereof from thetray 300.

The tray 300 in the illustrated embodiment is configured to seat aplurality of cervical screws 320 (see FIGS. 10 and 11). The information305 thus identifies the tray as an “RFID Enabled Cervical Screw Caddy.”

Another embodiment of an implant tray 400 configured to seat a pluralityof surgical devices therein is illustrated in FIGS. 12-14. The tray 400can generally be configured and used similar to the tray 300 of FIGS.9-11, with lids 446 covering a plurality of recesses 404 formed in thetray 400, with a parent RFID tag 407 attached to the tray 400, and withchild RFID tags 432 attached to surgical devices seated in the tray 400.The tray 400 in this illustrated embodiment seats a plurality of setscrews 428.

FIG. 15 illustrates another embodiment of a tray 500 configured to seata plurality of surgical devices therein. The trays 100, 200, 300, 400discussed above are referred to as “implant” trays and are illustratedas seating surgical implants, but the trays discussed herein can beconfigured to seat surgical implants other than those illustrated, e.g.,rods, plates, clips, etc., and surgical accessories, e.g., sutures,gauze, etc., configured to be used once with a patient. The instrumenttray 500 is configured to seat surgical devices in the form of surgicalinstruments, e.g., scalpels, staplers, retractors, cannulas, scissors,etc., which are configured to be used multiple times with multiplepatients. The instrument tray 500 can have a plurality of apertures 562formed therein for allowing a fluid (liquid, gas, or both) to passtherethrough, such as during sterilization and/or washing. The apertures562 can be circular, as shown, but can be of any size and shape thatdoes not compromise a structural integrity of the instrument tray 500,and can be arranged in any pattern along surfaces of the instrument tray500. The instrument tray 500 can have one or more handles 564 attachedthereto, which can facilitate carrying and other transportation of theinstrument tray 500. The instrument tray 500 can have a variety ofshapes, e.g., to fit into a storage area or an autoclave, such as asubstantially square shape as in the illustrated embodiment.

A parent RFID tag 507 can be attached to any part of the tray 500, inany of a variety of ways. The parent RFID tag 507 can be eitherremovably or permanently attached to any portion of the tray 500, asmentioned above, including to the handle(s) 564 attached to the tray500. Also as mentioned above, the parent RFID tag 507 can be configuredto undergo multiple sterilizations and/or to be reprogrammable, and canbe configured to store information relating to the tray 500 and/or tosurgical devices (not shown) seated therein. The parent RFID tag 507 isshown in the illustrated embodiment as being attached to an externalsurface of the tray 500 by being snap fit thereon via a casing enclosingthe parent RFID tag 507.

As shown, the tray 500 can be configured to seat a plurality of the sameor different types of surgical devices. The tray 500 can include aplurality of supports 566 configured to support various portions ofsurgical devices. By way of non-limiting example, each of the supports566 can have at least one prong 568 formed on an upper end of thesupport 566, such that the surgical device can be seated within a recess570 formed by adjacent prongs 568 a, 568 b on the same support 566. Asurgical device can be seated in only one of the supports 566, or thesurgical device can be seated in a plurality of the supports 566, witheach of the supports 566 configured to receive a particular portion ofthe surgical device. The supports 566 can be formed on or fixed onto abottom panel 542 of the tray 500, or the supports 566 can be removablyinserted into one of a plurality of support slots 574 formed in, e.g.,the bottom panel 542 of the tray 500 such that different supports 566can be selectively removed and attached to accommodate differentsurgical devices. The supports 566 can be of any width and any height,and the prongs 568 a, 568 b can similarly have any dimension. Thesurgical devices can be removably secured within the recesses 570 by,e.g., snap-fit, a light adhesive, interference fit, etc.

One embodiment of a surgical instrument 520, e.g., a driver configuredto drive a spinal anchor into bone, that can be seated in the instrumenttray 500 is shown in FIG. 16. The surgical instrument 520 can include ahandle 576 and an elongate shaft 578 extending distally from the handle576.

The surgical instrument 520 can have a child RFID tag 532 attachedthereto. The child RFID tag 532 can be attached to the surgicalinstrument 520 in a variety of ways, as discussed above. As in theillustrated embodiment, the child RFID tag 532 can be embedded in thehandle 576 in a closed cavity 535 formed therein. FIG. 16 shows thechild RFID tag 532 outside of the cavity 535 for clarity. Having thechild RFID tag 532 attached to a portion of the surgical instrument 520typically not inserted into a patient's body, e.g., in a handle, canhelp protect the child RFID tag 532 from damage during use of thesurgical instrument 520, e.g., to protect the child RFID tag 532 fromexposure to liquid at a surgical site. The handle 576 can include aremovable cap 582 attached to a proximal end of the handle 576 that canbe configured to be removably and replaceably attached thereto toprovide access to the child RFID tag 532, e.g., for technology upgrades,maintenance, replacement, etc. The removable cap 582 can have any size,shape, and configuration and can be attached to the handle 576 in anyway, e.g., matable threads, snap fit, interference fit, etc.

As mentioned above, trays having parent RFID tags attached thereto andhaving surgical device(s) seated therein, which have child RFID tagsattached thereto, can be transported between different locations toallow the surgical device(s) to be available for use in a surgicalprocedure. One embodiment of a process 700 of surgical devicedistribution is shown in FIG. 17. It will be appreciated by a personskilled in the art that the process 700 shown in FIG. 17 is anillustrative, non-limiting example of a process that can be used indistributing trays and surgical devices.

In the process 700, a tray can be assembled (s1) either manually, e.g.,by a representative of a medical device company, or by using anautomated method, e.g., by an assembly line. The assembly (s1) caninclude seating a plurality of surgical devices in the tray. A childRFID tag, which can be contained within a child RFID tag assembly, canbe attached to each of the surgical devices seated in the tray, eitherprior or subsequent to seating of the surgical devices in the tray, ifthe child RFID tags are not already attached thereto, e.g., permanentlyembedded therein. In an exemplary embodiment, every recess 104 formed inthe tray and/or every support mated to the tray can have a surgicaldevice seated therein, although any number of the recesses and/orsupports can be left empty, such as to reflect a specifically orderednumber of surgical devices for a specific surgical procedure. Assembling(s1) the tray can include attachment of a parent RFID tag to the tray inany number of ways, as mentioned above, if the parent RFID tag is notalready attached to the tray. As mentioned above, each child RFID tagcan be programmed to store information that can uniquely identify thesurgical device to which it is attached, and the parent RFID tag can beprogrammed to store a “master” list that can uniquely identify all ofthe surgical devices seated within the tray. The programming of theparent RFID tag and of the child RFID tag(s) can both occur prior toassembling (s1) the tray, subsequent to assembling (s1) the tray, or acombination thereof.

The parent RFID tag and the child RFID tag(s) can be scanned (s2), e.g.,manually by the representative using an external reading device, orautomatically, e.g., using an external reading device mounted to an trayconveyer belt. The scan (s2) can also optionally include manualinspection of information on the tray and/or information on the surgicaldevices and/or child RFID tag assembly/ies. The results of the scan (s2)can indicate that all of the necessary surgical devices are seatedwithin the tray, such as by manual comparison of the scan of the parentRFID tag with the scan of the child RFID tag(s) or by using an automatedchecking method, e.g., a comparison process run on a computer, as willbe appreciated by a person skilled in the art. The scans can optionallybe recorded or stored in a secure location for, e.g., comparison withsubsequent scans of the parent RFID tag and the child RFID tag(s),verification that all the correct surgical devices were initially seatedin the tray prior to shipment, etc.

The tray, along with all of the surgical devices seated therein, can beshipped (s3) to an order destination, such as a hospital or othermedical facility, in any way. The tray and the surgical devices seatedtherein can be sterilized (s4), such as at the order destination. Thetray and the surgical devices can be sterilized (s4) in any way, as willbe appreciated by a person skilled in the art, such as beta or gammaradiation, ethylene oxide, steam, and a liquid bath (e.g., cold soak).Once sterilized (s4), the tray and the surgical devices seated thereincan be delivered (s5) to an operating room, or other appropriatedestination, for use in surgery. Medical personnel can then perform (s6)the surgery, during which any number of the surgical devices seated inthe tray can be removed therefrom and used in performing the surgery.After the surgery is performed (s6), the tray and any remaining surgicaldevices seated therein can be cleaned and decontaminated (s7), in anyway, as will be appreciated by a person skilled in the art.Alternatively, the surgery may not be performed, e.g., if the patient'scircumstances have changed such that the surgery is canceled. The trayand any remaining devices seated therein can be, but need not be,cleaned and decontaminated (s7) after the decision is made to notperform the surgery. Similarly, the tray and any devices seated thereinmay not yet have been sterilized before the decision is made to notperform the surgery, in which case sterilization thereof can be, butneed not be, performed.

Post-surgery, or after a determination that surgery using the tray andthe surgical device(s) seated therein will not be performed, the trayand any remaining surgical devices seated therein can be shipped (s8) toa sterilization center, where the tray and any remaining surgicaldevices seated therein can be sterilized (s9) in any way and shipped(s10) to a receiving center. At the receiving center, the parent RFIDtag and any remaining child RFID tags can be scanned (s11), manuallyand/or automatically. The scan (s11) of all of the child RFID tagsattached to any surgical devices remaining in the tray can produceinformation, e.g., child information, uniquely identifying the surgicaldevices remaining in the tray. The scan (s11) of the parent RFID tag canproduce “master” information, e.g., a “master” list, which can includeinformation uniquely identifying all of the surgical devices in the trayat the time of the earlier scan (s2). In some embodiments, the scan(s11) of the parent RFID tag may not produce a master list but insteadproduce information that can allow access to a previously stored masterlist, e.g., by looking up a previously stored master list for a uniqueidentification code identified via the scan (s11). Following the scan(s11), a determination (s12) of which surgical devices have been removedfrom the tray can be performed, either manually, e.g., by therepresentative, or by using an automated method, e.g., an electroniccomparison performed by a processor (e.g., a central processing unit(CPU) of a computer), and can involve comparing the “master” list withthe information gleaned from the scan (s11) of each of the remainingchild RFID tags. The determining (s12) can produce an accurate resulteven if one or more of the surgical devices were simply moved todifferent positions within the tray. Using FIG. 1 as a non-limitingexample, if the spinal anchor originally seated in position a1 wereremoved and the spinal anchor originally seated in position a2 weremoved to position a1, comparison of the post-surgery scan (s11) wouldstill result in a determination that the spinal anchor in the positiona1 was the only surgical device removed from the tray 100.

Referring again to FIG. 17, having determined (s12) which of thesurgical devices, if any, were removed from the tray, a customer, e.g.,the hospital, can be billed (s13) for the surgical devices that wereremoved from the tray. As will be appreciated by a person skilled in theart, the customer can be billed for additional costs, e.g., shippingcharges, labor, etc.

The tray can be restocked (s14) to replace any missing surgical devices,with similar or different surgical devices. The restocking (s14) can beperformed in any number of ways, as will be appreciated by a personskilled in the art, such as manually by the representative, or by usingan automated method such as an assembly line. Each of the newly addedsurgical devices can have a child RFID tag attached thereto. The parentRFID tag attached to the tray can optionally be removed and reattached,or the parent RFID tag can remain attached to the tray and can bereprogrammed with a new “master” list of information uniquelyidentifying each of the surgical devices seated in the tray after therestocking (s14). The distribution process 700 can then be repeated anynumber of times by scanning (s2) the tray's parent RFID tag and thesurgical devices' child RFID tags.

As the distribution process 700 can be repeated any number of times, thesame tray, the same parent RFID tag, the same child RFID tags and thesame surgical devices can experience multiple distribution cycles. Theexemplary distribution process 700 can be used with any surgical devicecarrying apparatus and any number and combination of surgical devices,either same or different, seated therein. The process 700 can vary indifferent cycles of the process, e.g., as to the geographical locationto which the tray is shipped. The process 700 can be modified in avariety of ways, such as to provide additional scans of the parent RFIDtag attached to the tray, e.g., after the tray is shipped to a hospitaland/or after decontamination following surgery, and such as billing thecustomer once every several distribution cycles, e.g., after multiplesurgeries, rather than once at the end of each distribution cycle.

The surgical devices disclosed herein can be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the surgical device can be reconditioned forreuse after at least one use. Reconditioning can include any combinationof the steps of disassembly of the surgical device, followed by cleaningor replacement of particular pieces, and subsequent reassembly. Inparticular, the surgical device can be disassembled, and any number ofthe particular pieces or parts of the surgical device can be selectivelyreplaced or removed in any combination. Upon cleaning and/or replacementof particular parts, the surgical device can be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a surgical device can utilize avariety of techniques for disassembly, cleaning/replacement, andreassembly. Use of such techniques, and the resulting reconditionedsurgical device, are all within the scope of the present application.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

The invention claimed is:
 1. A radio frequency identification (RFID) assembly, comprising: a thumb grip, comprising: an annular disc including a proximal surface and a distal surface; a protrusion extending from the proximal surface; and a threaded distal portion extending from the distal surface; and a RFID tag rotatably secured to the threaded distal portion, wherein the RFID tag is disposed within a casing having a bore extending therethrough, wherein the threaded distal portion includes a rod extending from a distal end of the threaded distal portion, and Wherein the rod is disposed within the bore of the casing to rotatably secure the RFID tag to the thumb grip.
 2. The RFID assembly of claim 1 , wherein a knob having a diameter greater than the bore is disposed at the distal most end of the rod and is configured to retain the RFID tag on the rod.
 3. The RFID assembly of claim 1, wherein the thumb grip and the RFID tag are non-removably mated to one another such that they can be installed in a surgical instrument or implant as a single assembly.
 4. The RFID assembly of claim 1, wherein the threaded distal portion is cylindrical and includes threads that extend around the threaded distal portion more than one full rotation but less than two full rotations.
 5. A radio frequency identification (RFID) assembly, comprising: a thumb grip, comprising, an annular disc including a proximal surface and a distal surface; a protrusion extending from the proximal surface; and a threaded distal portion extending from the distal surface; and a RFID tag rotatably secured to the threaded distal portion, wherein the assembly is configured to be inserted in a surgical instrument or implant, and wherein the RFID tag stores information uniquely identifying the surgical instrument or implant, how many times the surgical instrument or implant has been sterilized, and how many times the surgical instrument or implant has been transported between different geographical locations.
 6. The RFID assembly of claim 5, wherein the surgical instrument or implant is a bone anchor.
 7. The RFID assembly of claim 1, wherein: at least one of the proximal surface of the annular disc and a surface of the protrusion includes visually indentifying information of a surgical instrument or implant.
 8. A method of securing a radio frequency identification (RFID) assembly within a surgical instrument or implant, comprising: gripping a thumb grip having a proximal gripping portion, an annular disc, and a distal shaft to which an RFID tag is rotatably mated; inserting the RFID tag and at least a portion of the distal shaft within a recess of a surgical instrument or implant; rotating the thumb grip relative to the surgical instrument or implant and relative to the RFID tag to secure the thumb grip and the RFID tag within the surgical instrument or implant; and storing information on the RFID tag including at least one of how many times the surgical instrument or implant has been sterilized and how many times the surgical instrument or implant has been transported between different geographical locations.
 9. The method of claim 8, wherein rotating the thumb grip comprises: rotating the thumb grip at least a full rotation and at most less than two full rotations to secure the thumb grip and the RFID tag within the surgical instrument or implant.
 10. The method of claim 8, further comprising: storing information uniquely identifying the surgical instrument or implant on the RFID tag.
 11. The method of claim 8, further comprising: labeling at least one of a top surface of the annular disc or a proximal face of the proximal gripping portion with indentifying information of the surgical instrument or implant.
 12. The method of claim 11, wherein the thumb grip further includes a threaded distal portion extending distally from the annular disc and the distal shaft extends from the threaded distal portion.
 13. The method of claim 12, further comprising: threading the threaded distal portion of the thumb grip into the recess formed in the surgical instrument or implant.
 14. The method of claim 8, further comprising: inserting the RFID tag within a casing, the casing being rotatably secured to the thumb grip.
 15. A radio frequency identification (RFID) tag assembly, comprising: a RFID tag case including: a length and a width; a bore disposed at a midpoint along the length of the case; and a RFID tag disposed within the case; and a thumb grip assembly including: a disc including a top surface having a generally rectangular protrusion extending proximally therefrom and bottom surface having a cylindrical protrusion extending distally therefrom; a rod extending distally from the cylindrical protrusion; a knob disposed at a distal most end of the rod; and a knob having a diameter that is larger than the diameter of the bore, wherein the RFID tag case is rotatably secured on a distal end of the thumb grip assembly.
 16. The RFID tag assembly of claim 15, wherein the length of the RFID tag case is larger than the diameter of the disc. 